Wednesday, January 14, 2009

Albuterol and Political Correctness

Nobody get all prescriptive versus descriptive linguistics on me, but I'm noting a bizarre thing lately. It may not be new, but there's this odd tendency for people to call decisions or acts that they disagree with that they think are clearly done to please somebody not them "politically correct."

There's a fair deal of politics in this post, but I swear it's about a pharmacy-related issue.

Political correctness, PC-ness or PC-ism is a term mostly associated with liberals and liberal thinking. The basic gist of PC-ness is the idea that you shouldn't offend people, but it extends beyond that; you shouldn't do things that might offend people. Furthermore, everything you do is potentially offensive to someone, no matter how mundane it seems to you. Taken to its extreme, PC-ness is "left-wing censorship." It is frequently assumed within the context of PC that white males are not really offended by anything, but that women, racial minorities, and religious minority groups are "sensitive" to "careless speech." Women in particular are used as an example, partly because some feminist groups really do go way too far, insisting that the word "human" is offensive because it contains the word "man" and that alternative terminology needs to be developed.

The idea of what is and is not offensive is highly affected by cultural and subcultural norms, so I'm not even going to go into that. You could write a book on the subject. I'm sure someone has.

What I'm going to take issue with is the use of the phrase PC being grossly misapplied and my understanding of why it happens. The most recent example of this that I've seen was when I, out of morbid curiosity, clicked a link to "saveCFCinhalers.org" (I'm not going to link them because I don't want to boost their google ranking).

Summary: CFCs, or chlorofluorocarbons, are compounds that have been used as aerosol propellants and refrigerants for roughly the past century. CFCs react with ozone in the upper atmosphere and catalyze its destruction. Because CFCs are a catalyst, they are not used up in the reaction, so a single CFC molecule may destroy a number of ozone molecules, converting them to oxygen. Ozone blocks ultraviolet radiation, specifically UVB rays. It is well-established that CFCs deplete ozone and that this will increase the amount of UVB rays that reach the earth's surface. CFCs were phased out of aerosol paints and other products during the last decade. 2008 was the last year that CFCs could be included in metered-dose inhalers (MDIs, or "puffers").

MDIs containing a different, non-CFC propellant (HFA inhalers) have been on the market since 1996. As of December 31st, 2008, CFC inhalers may no longer be sold and supplies have basically been exhausted anyway since nobody has been making them for a while. The most commonly used MDIs are albuterol "rescue inhalers" that expand the passageways in the lungs. This is a big deal drug--if you want to know what it's like to have an asthma attack, go get a straw. Put it in your mouth. Breathe only through the straw without opening your mouth wider or using your nose.

Anyway, the old inhalers have been replaced with environmentally-friendly versions. Same drug, same dose, same efficacy. Some people are throwing a fit about this.

There are a few big complaints.

1. The HFA inhalers cost a little more. The old albuterol generic was about $25, less if insurance picked up part of the tab. The new inhalers are about $35-40 and insurance pays less since they're generally "brand name" products now. The whole insurance payment thing might change soon if enough people complain about it.

2. The HFA inhalers don't "feel" the same when sprayed--they're a bit less "forceful," which leads people to think that they don't work.

3. The propellant contains a very tiny amount of ethanol, which might leave a bad taste in the user's mouth. It is not enough to get you drunk by any stretch of the imagination.

The websites railing against HFA inhalers are full of comments that basically tell the same story. My inhaler doesn't work anymore. My daughter changed to an HFA inhaler and she died of an asthma attack a few months later. I changed to an HFA inhaler and now I have a huge long list of health problems I didn't have before. The government and the FDA are ripping us off and lying about the safety and efficacy of HFA inhalers. Here's a list of doctors that don't believe the HFA inhalers work as well. The American Lung Association is full of shit. Etc. I actually got into an "argument" of sorts with a coworker over this one day--not someone that works in the pharmacy. He was convinced that albuterol had been taken off the market completely and that you simply couldn't get it anymore, and when I informed him otherwise he seemed incredulous--but I didn't get an opportunity to talk to him about it further.

The comment that piqued my interest (and inspired this entry) was the complaint that CFCs had been removed from inhalers to "be politically correct."

I don't know exactly what train of thought the commentor used to get to that point, but here's how I see it. Before anyone accuses me of straw-manning anybody, I'm quoting statements made by my incensed coworker. While his thoughts may not be echoed by everyone who opposes this particular bit of regulation, this is the only dialogue I've had with someone who had a problem with the banning of CFCs on principle rather than because of some specific complaint (such as the new inhalers costing more).

1. Some people ("environmentalists") think that CFCs damage the ozone layer.2. People who want to be "environmentally-friendly" by using CFC-free products should have the right to buy them; let the market decide.3. I'm not convinced that CFCs damage the ozone layer.4. Not letting me choose which product to buy is an unfair limitation of my personal freedom.5. Therefore, a CFC ban limits my personal freedom.

This train of thought hinges on one particular premise, which, again, lest you think I'm constructing a straw man, was basically the crux of my coworker's entire argument: I'm not convinced that CFCs damage the ozone layer.

Let's go with the "free market" approach. In order to make an informed decision about which product is best, you have to understand several things. First, you have to know what the ozone layer is. Second, you have to know that CFCs damage the ozone layer. Third, you have to know the consequences of damaging the ozone layer. Once you have all of that information, you can make a choice: Do I care whether or not the ozone layer is damaged by the products that I use?

Here's the problem. This isn't a personal choice that's (primarily) going to affect only you, like what color to paint your shutters or whether or not to snort cocaine. Your decision is going to affect everyone living on the Earth for at least the next 50 years, which is how long an individual CFC molecule can remain in the atmosphere destroying ozone molecules. You are contributing to an increase in UVB radiation reaching the planet's surface during your lifetime, much of your children's lifetime, and at least part of their children's lifetime. You are increasing the risk of skin cancer for everyone alive now and everyone who will be born over the next several decades.

Frankly, I don't think you should be allowed to make that decision any more than you should be allowed to shoot me and take my wallet or dump sewage on my property, and the fact that you're too short-sighted to see the consequences of your actions shouldn't affect my personal health. I have rights too, you know.

(Incidentally, to preempt the slippery slope, I don't favor smoking bans because if second-hand smoke bothers you, don't go where people are smoking. If the owner of a particular piece of property opts to ban smoking for the comfort of their non-smoking patrons, that's their call, but nobody should be able to tell you you can't smoke outside or in your own car--though exposing your kids to second-hand smoke is certainly irresponsible and I have mixed feelings about it.)

What does any of this have to do with PC-ness?

Well, PC-ness is about not offending people. One of the things that I've heard said several times, more by conservatives than by liberals, is that "you don't have a right to never be offended," and I agree. Sometimes, people are going to do or say offensive things, and unless they're hurting you or there's a specific rule against whatever they're doing (sexual harassment at work, for example), you just have to get over it and move on. That doesn't mean you have to like it, and you can certainly say you don't like it, because criticism is not the same thing as censorship. Plus, some things are just socially unacceptable within a specific culture because enough people have decided that they don't like thing X that doing or saying thing X will get you publically ostracized (being openly racist in many circles in the US is a good example).

At this point, environmentalists become a minority group identified by a set of opinions or beliefs. If you don't accept the whole CFC-ozone layer thing, you might call it an "environmentalist belief," which puts it on par with any other faith-based assumption that you don't share. At that point, the government banning CFCs does seem like a "PC thing." They're doing it to appease some minority's feelings.

Which means that you're treating the CFC-ozone "belief" kind of like the beliefs of religious groups that are not your own. It's like if the government banned pork products because Muslims consider them unclean. You don't care what Muslims believe if you aren't one. Why should the "belief" of a minority group infringe upon the rights of the majority? Stupid political correctness!

Here's the part of all this that I don't entirely comprehend. Conservatives are generally very black-and-white--things are true, or they aren't. They pride themselves on being practical thinkers and denounce liberals as naïve idealists. The reason I think that this is funny is because calling evidence-based environmentally-friendly legislature "PC" is essentially invoking a kind of relativism. "You and I believe different things. Neither one of us can produce proof that will convince the other, so let's just agree to disagree." Except that you can't do that, because whether or not CFCs affect the ozone layer (for example) isn't a matter of opinion. It's either true or it isn't. And if we're talking about laws, something is either a law or it isn't; we have to decide. To "agree to disagree" in that context is to suggest shutting down dialogue on the subject--therefore, nothing is changed and the conservative viewpoint "wins" by default.

Inappropriate use of relativism regarding what is valid knowledge--which I see on both the far left and far right--is actually an interesting enough topic to warrant its own post, and I might have to make one later.

So. Here's the tl;dr summary: You can't criticize someone for being "PC" when what they're doing is not about avoiding offending people but about responding to objective, measurable conditions. This is true even if you think that the thing being done is intended to appeal to a "minority group" because you don't care about the issue at hand. Using the phrase PC doesn't make a damned bit of sense--but as with all language, you're free to use the phrase to mean whatever you want. You just shouldn't expect your listener to interpret what you're saying properly.

36 comments:

I know its not the main subject, but... The reason most people think that the HFA MDI's don't work as well is because they were never using their MDI correctly. The lower force that comes from an HFA inhaler makes it more important for people to use their inhaler correctly. If they were using their rescue inhaler CORRECTLY they would not notice a difference.

You're all on crack. People that have had success for 20 and 30 years with CFC inhalers suddenly don't know how to use an MDI correctly?! That's hilarious. Just for the sake of argument take a look at every link below and then make the case that all 4500+ people are incapable of working an MDI. I personally know someone who is a Phd who feels his life is at risk because of the new MDI. Are you going to tell him he isn't smart enough to operate an MDI?! Hilarious! You must have asthma and have tried the HFA inhalers to even understand just how bad they are.

Actually I have no problem believing that 4500 people do not use their MDI correctly. A study done in the 90's found that only about 11% of patients do all recommended steps when using their MDI. With 2 million asthma patients that makes plenty of room for 4500 patients that do not used their inhaler correctly enough to make up for the lower pressure exerted by the HFA's.

I agree with FuturePharmer - most folks don't use the HFAs correctly. They are different from the CFC inhalers - they feel different - in the mouth, throat, shaking - all of it.

This is not news. Albuterol was given a 10 year reprieve. We are not going back. This was a world wide decision & it won't change.

What needs to change is the patients. This is a perfect opportunity to teach them how to use "this" inhaler. Don't tell them they were using the other one wrong (altho that squirt in the back of the throat was reinforcement). Just say, now the vehicle is changed, I need to explain to you how to use THIS one effectively.

I assume the writer has never had a life threatening asthma attack. Those of us who have are in an uproar because the only drug that works in this event was yanked from the market for political reasons. It not off market for any other reason. It was replaced by four more expensive name brands with unknown long-term side effects. None of them work well. The individual clinical trials were short and used a miniscule amount of the total population. The drug company itself conducted the trials. I am a green type person with a very small carbon footprint.

I assume the writer has never had a life threatening asthma attack. Those of us who have are in an uproar because the only drug that works in this event was yanked from the market for political reasons. It not off market for any other reason. It was replaced by four more expensive name brands with unknown long-term side effects. None of them work well. The individual clinical trials were short and used a miniscule amount of the total population. The drug company itself conducted the trials. I am a green type person with a very small carbon footprint.

Personal attacks are not a substitute for evidence. Neither are anecdotes and testimonials. Large, randomized, well-designed clinical trials have demonstrated equivalent efficacy between HFA and CFC inhalers. If you have new credible evidence to present, do so.

There are four brand name albuterol products each requires a unique prescription. The prescriptions are not interchangeable nor are they interchangeable with a CFC albuterol prescription. All albuterol is not the same. A pharmacist or a would be one should know this. The large trials were too randomized to be accurate as all albuterol is not equal. They were also short. No one knows the long term effects of these drugs. You are shooting off your mouth on a subject about which you know nothing while insulting everyone who has a problem with the new medication. Grow up.

I does suck that it costs more...certainly because the HFA version has been on the market for 13 years. Why didn't they release it as a generic by now? Mainly because IT IS the same medicine, with a different propellant.

Also..."very tiny amounts of ethanol".....laughable. I'm having an attack and my lungs are lacking oxygen, and you want me to suck in "a very tiny" amount of ethanol? None for me thanks, as it burns my throat and lungs, and I'd rather have something that soothes my breathing passage thank you very much.

I had to rely on Primatine for years and years because I couldn't afford the CFC inhaler....and I hated that product because it was low dose "speed drug" mixed with ethanol. It worked for my breathing, but I got jitters, and boy did my throat sting for a bit.

I've always wondered why something so bad for asthmatics (and Primatine is bad for you), can be sold over the counter while good inhalers are still prescription only???

If Zantac, a medicine that works against heartburn and GERD, but also proven to HEAL ulcers, can go over the counter so quickly, why is Ventolin still, and seems to forever be prescription only?

2) Over the counter meds for asthma sufferers are bad for you. (Speed kills you know)...and why isn't the medication that has been proven to work still only available by prescription only?

3) CFC inhalers have been used for thirty plus years and have worked better than ANY OTHER FORM of the medication.

5) Get rid of the gasoline combustion automobile first and then we can talk about me changing over to an CFC free propellant. I would have to say that all the possible billions of little canisters produced in our lifetime wouldn't release enough CFC's in the air as Los Angeles does in a day.

Michael T, comments like yours are precisely the sort of ignorance that the Secundum is talking about. I'll just point out the most egregious issue: Internal combustion engines don't produce CFCs. They don't have any byproducts that are relevant to the ozone layer.

Incidentally, I'm not sure this post gives enough to credit to the issue of cost given that asthma is very much an inner city problem. So the additional cost could have a disproportionate impact than one would expect.

HFA albuterol is not as safe and is also not as effective as CFC albuterol. This is admitted by one of the manufacturers of HFA inhalers and is on the FDA's own website.

http://www.fda.gov/cder/foi/nda/2001/20-983_Ventolin-HFA_medr_P1.pdf

These quotes taken directly from the new drug application for Ventolin HFA.

"In the multiple dose adolescent and adult studies, albuterol HFA showed a numerically smaller improvement in FEV1 than was seen with albuterol CFC"

"There was other evidence that the HFA formulation delivers a lower/less effective dose on a per acutation basis than the CFC product. In the single dose, dose ranging study in adults, and in the single dose methacholine challenge study in adults one and two acutations of albuterol CFC were statistically indistinguishable in terms of effect, whereas significant differences were seen between one and two acutations of albuterol HFA. Finally, the combined adolescent/adult studies showed that the HFA formulation had a longer median time to onset of effect(4.2-9.6 minutes versus 3.6-4.2 minutes), had a shorter duration of effect(1.55-3.30 hours versus 2.29 - 3.69 hours), and was associated with more albuterol 'back up' use than the CFC formulation."

"Because it is expected that many physicians will prescribe Ventolin HFA Inhalation Aerosol for patients who have previously used the CFC formulation, it would be appropriate to include some description of the relative effectiveness of these two formulations in the product label."

Thanks for the great blog. I really enjoyed reading it. In fact if I were you I would go to http://www.autosurfmonster.com/ and submit this blog so thousands of others can see it for free. I am not trying to advertise for anyone, I just feel like more people should have the opportunity to see this blog and I also got a lot of free hits from them for my own blogs.. Well anyways, I look forward to all the updates.

After 6 month of a ban on CFC there is enough evidence that there is a subset of patients for whom CFC inhalers work, and HFA do not.

My daughter is one of them. She is a PhD, used CFC inhalator for years, and definitely followed all the steps: cleaning, priming, etc.

The right thing to do is for FDA to do a post market research and follow up on complaints: there are hundreds, if not thousands recorded with FDA. It does not take a lot of time or money to follow up with those people to check if they use their new inhalers correctly, and if they get or do not get the same relieve.

FDA refuses to do it, because they know that if they do, they will find out that HFA does make some people sicker, so they will have a huge political problem on their hands.

It seems absurd and inhume that people with asthma are denied this life-saving drug.Now would be a good time to start complaining in earnest because it would save a lot of money for overburdened health care. It saves money on the cost of the inhaler and huge money that will get spent on hospital visits, more illness and more drugs and then more doctors for all the side effects. Or we could use a generic inhaler.

People that have a REAL asthma problem, know how to use an inhaler. When you're gasping for every breath, it is difficult to inhale slowly, continue inhaling for 3-5 seconds, and hold your breath for 10 seconds. The old propellants were much better. I gotta believe that there are more pressing CFC causing agents out there.

BrainStorm Transcription Services is well aware of its professional obligations towards HIPAA regulations. We continuously upgrade our knowledge base and transcription systems to comply with HIPAA regulations.

BrainStorm Transcription Services is well aware of its professional obligations towards HIPAA regulations. We continuously upgrade our knowledge base and transcription systems to comply with HIPAA regulations.

What is "secundum artem?"

Secundum artem is a Latin phrase meaning "according to the art." It is frequently used to doing something in the accepted manner of a skill or trade; in medicine, it is often taken to mean "use your skill and judgment."

Secundum Artem, then, is a blog about pharmacy written by a pharmacy student. But it is also about more than pharmacy; it is a collection of one man's thoughts about medicine, science, politics, ethics, life, and the connections between them.

Unfortunately, we live in a sue-happy world, so I have to include a brief disclaimer.

DISCLAIMER:This is a personal weblog, and the opinions expressed here are solely those of the author. All medical information on this blog is intended for discussion and entertainment only; it should not be used as a sole source of medical advice, and anyone following any recommendations provided here by the author or by commentors without first consulting a physician shall be required to take full responsibility for the consequences.

Who writes Secundum Artem?

S.A. is written by N.B., a pharmacy student with a lot on his mind. He's a fan of self-reference, irony, critical thinking, and writing blog descriptions in the third person.

Give him a couple more years, and he'll be able to call himself N.B., PharmD, RPh (but probably won't, because that is one pretentious mouthful).